This webinar is part of the The Compliance Playbook - Register for other sessions here 

Join us for another content-filled webinar  

It can be overwhelming navigating the evolving requirements pertaining to records management in electronic systems, even for the more experienced validation veteran. In this webinar, members of Montrium’s Professional Services team will share key insights on Office 365 validation to serve your clinical and regulatory needs.  

Ultimately, the responsibility to validate GxP applications is on customers and partners of Microsoft - so we’ll take a look at how to build out a validation plan and control protocols for successful integration with your existing system.  

We’ll uncover how Office 365 satisfies specifications of FDA’s 21 CFR Part 11 and EU Annex 11 from both a procedural and technical approach to satisfy regulatory conditions, and how the balance of shared responsibilities between Microsoft and its life sciences customers can satisfy regulatory requirements.  

After the webinar, participants will sign off having a clearer overview of how to adapt validation techniques to the cloud, as well as key validation expectations and deliverables in Office 365.

The webinar will cover the following topics: 

  • Preparation and adaptation of validation deliverables
  • How to build a validation plan: scope and risk rationale 
  • Risk-based validation planning
  • Regulatory compliance impact assessments for Office 365 
  • Components to be qualified and validated in the cloud
  • Developing a validation summary report 
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